CN110267591A - High flexibility mapping and therapeutic equipment - Google Patents
High flexibility mapping and therapeutic equipment Download PDFInfo
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- CN110267591A CN110267591A CN201880008667.2A CN201880008667A CN110267591A CN 110267591 A CN110267591 A CN 110267591A CN 201880008667 A CN201880008667 A CN 201880008667A CN 110267591 A CN110267591 A CN 110267591A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
- A61B5/283—Invasive
- A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
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- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
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Abstract
For providing the equipment and system of mapping and treatment ability of medicine without increasing equipment rigidity.Apparatus embodiments may include flexible elongated body and at least one is located at the mapping element in the slender bodies distal part.Each mapping element can be the region of Heat Conduction Material (such as metal nanoparticle), which is inserted into slender bodies, or integrated with slender bodies, or be deposited on slender bodies.The flexibility in Heat Conduction Material region is at least essentially identical with the flexibility of slender bodies, so that equipment can include multiple electrodes in the case where not losing Flexible Equipment and operability.Alternatively, equipment may include the therapeutic element for being coupled to slender bodies, such as sacculus.Mapping element can be inserted into sacculus, integrated with sacculus, or be deposited on sacculus, and can have at least essentially identical flexibility with the sacculus.
Description
Technical field
The present invention relates to for providing flexible equipment, system of the mapping function without losing equipment distal part to equipment
And method.
Background technique
Arrhythmia cordis is the normal rhythm and pace of moving things of heart and the patient's condition that cardiac performance is disturbed, and is usually passed by (multiple) abnormal current
Broadcasting is caused by cardiac muscular tissue.The effect of currently used a variety of rhythms of the heart are treated needs the realization before delivering is treated very accurate
Therapeutic purpose (for example, the region for the destination organization that abnormal current propagates through) positioning.
No matter treatment be related to delivering drug, some form of energy be applied to target, energy is removed from target or
It is mechanically to influence destination organization, it is necessary to know the exact position of the target.Standard imaging techniques are available and can be in target quilt
It is used when visualization, fluoroscopy, ultrasonic wave, computed tomography (CT) or magnetic resonance imaging (MRI) etc..Some
In the case of, target position is invisible, and is to rely on the mark of the electrical properties to periplast (substrate).
In some type of arrhythmia cordis, it by myocardial spread electric current be used to that electrophysiologist be guided to find to be treated
Accurate location.In general, this is completed by the high density electrical mapping of part of heart or entire heart.Electricity can be used in various mappings
Pressure, frequency and activation mapping etc. generate.The heart of one of these mappings visualization technique that usually text is discussed in use exploitation
Dirty 3D is overlapped on rebuilding.
Although most visualization techniques are passive (with regard to the technology itself not and by visually tissue geometry knot
Structure mechanically interacts simultaneously for therefore can't making deformed anatomy), but most electrical mapping technologies need to mark really
Survey the Mechanical Contact between conduit (or array) and cardiac muscle.
Most of conduits or mapping array have one or more flexible members, the flexible member bearer connection to electric wire
Electric signal from cardiac muscle is back to acquisition and processing system by metal electrode, the electric wire.The flexibility of component determines this process
The middle deformation being subjected on mapping region.The even component (component such as manufactured by flexible polymer) of highly flexible
It can be influenced by the presence of metal electrode, which is usually attached to platinum-iridium (PtIr) band on compliant member surface.This
A little electrodes are usually inflexible, and will cause extremely mounted zone-hardened of device power.Additionally, in most cases
Electrode retaining collar or electrode band are all forged and pressed on flexible member, cause polymeric support to be compressed, therefore further decrease flexibility.In electricity
The adhesive and will also result in its hardening across a large amount of electric wires of component that pole band lower section or edge use.
Additionally, some combination mappings and ablation apparatus include the mapping electrodes on the outer surface of inflatable element, all
Such as freeze sacculus.In this case, mapping electrodes electric wire is normally fed through the sacculus, so that electric wire reduction be presented or with it
His mode damages the risk of balloon integrity.Therefore, this configuration faces sacculus rupture and balloon interior fluid and may reveal
Into the risk of patient's body.
Summary of the invention
Some embodiments advantageously provide the equipment for providing in the case where not losing flexible situation and having mapping and treatment ability of medicine.?
In one embodiment, Medical Devices may include distal part, which includes: at least one therapeutic element, treatment member
Part has the first flexibility；And at least one mapping element, at least one mapping element are that have the second heat conduction material flexible
The region of material, second flexibility are at least flexible essentially identical with described first.
In one aspect of the embodiment, Heat Conduction Material may include nanoparticle.For example, nanoparticle can be metal
Nanoparticle.In one aspect of the embodiment, metal nanoparticle can be made of at least one of platinum and platinum-iridium.
In one aspect of the embodiment, distal part can further comprise at least one trace, at least one mark
Each of line and at least one mapping element communicate, and each of at least one trace is made of Heat Conduction Material.
In one aspect of the embodiment, each of at least one trace can have that third is flexible, the third flexibility at least with
Described first and second is flexible essentially identical.In one aspect of the embodiment, with it is each at least one mapping element
At least one trace of a communication may include the first trace being made of the first metal and the second trace for being made of the second metal,
First and second trace is thermocouple.In one aspect of the embodiment, the first metal can be one of gold and palladium,
Second metal can be platinum.
In one aspect of the embodiment, Medical Devices can further comprise slender bodies, and the distal portion is that this is elongated
The distal portion of body, at least one described mapping element are to be merged (incorporate) to the Heat Conduction Material in the slender bodies.
In one aspect of the embodiment, slender bodies can have a circumference, each of at least one described mapping element around
Entirety less than the circumference extends.
In the one side of the embodiment, at least one therapeutic element may include inflatable therapeutic element, this at least one
Mapping element is the region for the Heat Conduction Material being integrated into the inflatable therapeutic element.In one aspect of the embodiment,
Heat Conduction Material may include metal nanoparticle.In one aspect of the embodiment, distal part can further comprise at least one
A trace, each of at least one trace and at least one mapping element communicate, each at least one trace
It is a to be integrated into inflatable element.In one aspect of the embodiment, each of at least one trace can be by leading
Hot material is constituted.
In one embodiment, medical system may include Medical Devices, which includes: slender bodies, the slender bodies
With the first flexibility；And at least one is located at the mapping element on slender bodies, which is to have second
The region of Heat Conduction Material flexible, second flexibility are at least flexible essentially identical with described first.Medical system can be wrapped further
Control unit is included, the control unit and medical device communication.
In the one side of the embodiment, each of at least one mapping element may include communicating with control unit
Thermocouple, each thermocouple include the first trace being made of the first metal nanoparticle and by the second metal nanoparticle
The second trace constituted, each in first and second trace are embedded into slender bodies.In the one aspect of the embodiment
In, each of first and second traces of each thermocouple can have that third is flexible, the third flexibility at least with first and
Second is flexible essentially identical.In one aspect of the embodiment, slender bodies can have circumference, at least one mapping element
Each extends around less than the whole of circumference to limit gap in the mapping element.In the one aspect of the embodiment
In, at least one mapping element may include multiple mapping elements, these mapping elements are opened with spacing to each other and along slender bodies
Distance extends on distal side to proximal direction, and the first and second traces of each thermocouple prolong on the direction in distal side to nearside
Extend through the gap of next nearside mapping element.
In one embodiment, medical system can include: Medical Devices, the Medical Devices include: with flexible and extremely
The slender bodies of few substantially continuous circumference；Multiple electrodes on the slender bodies, multiple electrode are configured for recording
At least one impedance measurement, each of multiple electrode are the region of the heat conduction nano particle of the first metal, multiple electricity
Each of pole have flexibility, flexibility at least with slender bodies flexibility essentially identical, each of multiple mapping elements
Extend around less than the whole of the slender bodies circumference；And multiple traces with multiple mapping element telecommunication, it is multiple
Each in trace is the region of the heat conduction nano particle of at least one of the first metal, the second metal and third metal；
Medical system further includes the control unit with medical device communication, and the control unit is configured for connecing from multiple electrode
At least one impedance measurement is received, and is formed based on the damage at least one impedance measurement assessment tissue regions.
Detailed description of the invention
When considered in conjunction with the drawings, by reference to following detailed description, embodiment described herein will be more readily understood
More complete understanding and its adjoint advantage and feature, in which:
Fig. 1 shows the example medical system including Medical Devices；
Fig. 2 shows the close-up illustrations of the distal part of the Medical Devices of Fig. 1；
Fig. 3 shows the close up view of the further embodiment of Medical Devices distal part；
Fig. 4 shows the close up view of the further embodiment of Medical Devices distal part；
Fig. 5 shows the close up view of the further embodiment of Medical Devices distal part；
Fig. 6 shows the close up view of the further embodiment of Medical Devices distal part；
Fig. 7 shows the exemplary position of Medical Devices during therapeutic process；
Fig. 8 shows the further embodiment of Medical Devices distal part；
Fig. 9 shows the further embodiment of Medical Devices distal part；
The further exemplary position of Medical Devices during Figure 10 shows therapeutic process；
Figure 11 shows distal tip element；And
Figure 12 shows the further embodiment of distal tip element.
Specific embodiment
Equipment described herein has the ability of mapping and treatment in the case where not losing equipment distal part flexibility.?
It is described in detail before exemplary embodiment, it should be noted that passed through the ordinary symbol in attached drawing in suitable position to system and method
Composition indicated, these expressions only show and understand those of the related specific detail of embodiment of the disclosure, so as not to make
Benefiting from description herein becomes obscure for the disclosure of those of apparent details to those skilled in the art.
As used herein, such as " first (first) ", " second (second) ", " top (top) " and " bottom
Etc. (bottom) " relationship types term can be only used for distinguishing an entity or element and another entity or element, without
Centainly require or imply that there are any physics or logic relationship or sequences between these entities or element.It is used herein
Term is merely for for the purpose of describing particular embodiments, it is no intended to limit concept described herein.As used herein, singular shape
" one (a) " of formula, " one (an) " and " being somebody's turn to do (the) " are also intended to including plural form, except in addition context explicitly indicates.
It is to be further understood that as used herein, term " including (comprise) ", " including (comprising) ", " including
(include) ", and/or " including (including) " specifies the feature, integer, step, operations, elements, and/or components
Presence, but be not excluded for other one or more features, integer, step, operation, component, assembly unit and/or the presence of its group or
Addition.
Unless otherwise defined, all terms (including technical and scientific term) used herein have and disclosure institute
The identical meaning of the meaning that the technical staff in category field is commonly understood by.It is to be further understood that term used herein should
It is interpreted as having and their consistent meanings of meaning in the context of this specification and related fields, and should not be with idealization
Or meaning too formal is explained, unless clearly so limiting herein.
In embodiment described herein, " with ... communication (in communication with) " etc. is coupled term can be with
It is used to indicate that telecommunication or data communication, which can be for example, by physical contact, induction, electromagnetic radiation, aerogram
Number, infrared signal or optical signalling complete.Those of ordinary skill in the art will understand multiple components can interactive operation, and modify
The telecommunication and data communication may also be realized with deformation.
Referring now to attached drawing, wherein similar reference label refers to similar components, figures 1 and 2 show that medical system
Embodiment, the medical system are commonly labeled as " 10 ".One embodiment of system 10 may include navigation system 12, but the system 10
The operating console and Medical Devices 16 that may also include control unit 14 or communicated with navigation system 12 and control unit 14.System
10 can further comprise imaging system 18, which is used to obtain the image of anatomical features in patient body.
Medical Devices 16 can be treatment and/or mapping equipment.Medical Devices 16 may include can by the blood vessel of patient and/
Or the slender bodies 22 adjacent to the tissue regions for diagnosing or treating.For example, equipment 16 can be conduit, which can be through
Tissue regions are delivered to by sheath or intravascular catheter, or can be equipment, which can enter pericardial space.Slender bodies
22 can limit portions of proximal 26 and distal part 28 and longitudinal axis 30, and can further comprise being arranged in slender bodies 22
Interior one or more inner cavities, provide whereby machinery between slender bodies portions of proximal 26 and slender bodies distal part 28, electricity and/
Or it is in fluid communication.The slender bodies 22 can further limit circumference, which can be at least substantially continuous circumference (for example, such as
Shown in Fig. 1).
Medical Devices 16 can further comprise one or more therapeutic elements 34, which is located at slender bodies distal portion
It at points 28, is coupled to slender bodies distal part 28 or in slender bodies distal part 28, is used for and Medical Devices 16 and treatment
Energy, treatment and/or research interaction are carried out between position or region.(multiple) treatment region element 34 can be treated to (multiple)
Tissue regions (including heart tissue) near element deliver such as cold therapy, RF energy, ultrasonic energy, laser energy
Or other energy transmissions.For example, (multiple) therapeutic element 34 may include with the hot transit area of coolant or heat source thermal communication, with
The surface treatment element etc. of hot transit area, surface radio frequency electrode etc that power supply is electrically connected.In addition, equipment 16 may include
The therapeutic element 34 of more than one type.Further, if the equipment includes one or more therapeutic electrodes, each treatment
Electrode 34 can be considered as therapeutic element 34.In Exemplary System Embodiment shown in Fig. 1, equipment 16 may include nondistensible
Therapeutic element 34.The nondistensible slender bodies distal part 28 can be used as therapeutic element, such as, when one of distal part 28
Dividing whens conductive, thermally conductive, transmission laser energy, ultrasonic energy etc. and/or having inside the distal part 28 reduces the distal portion
When dividing the coolant circulation of 28 temperature.Additionally or alternatively, which may include one or more
It is configured for the therapeutic element 34 of energy transmission, the electrode being such as connected to energy source.Embodiment shown in Fig. 1, carefully
Long body distal part 28 can be used as the therapeutic element 34 for energy transmission, and may include multiple mapping electrodes 40.Alternatively, should
Multiple electrodes 40 may be configured for both mapping and delivering treatment energy.Further, multiple electrode 40 can also be matched
It is set to record and carrys out the impedance measurement of self-organizing for lesion assessment.
Slender bodies distal part 28 can be flexible.For example, distal part 28 can be at least substantially linear
It is converted between one configuration and the second configuration that is curve, loop or otherwise extending (for example, as shown in Figure 7).However,
It should be appreciated that any one in numerous mappings and energy transmission configuration can be used.
In another embodiment, equipment 16 may include inflatable therapeutic element 34, such as one or more sacculus.It is inflatable
Therapeutic element 34 can be coupled to a part of slender bodies distal part 28 (for example, as seen in figs. 8-10).Inflatable therapeutic element
34 can further comprise providing one or more material layers of puncture resistance, radiation impermeability etc..If equipment 16 is used for
Delivering cold therapy, (or if be used together with another form of energy, which requires delivering fluid to therapeutic element
34 inner cavity chamber), then the equipment may also include one or more fluid injection members.Equipment 16 may also include to be connected to energy source
One or more therapeutic elements, the one or more electrodes being such as connected to source or RF energy.Further, equipment 16 can
Including one or more mapping electrodes 40.Alternatively, equipment 16 may include inflatable element, which is not used to energy
Amount transmitting, but extended or inflated to support mapping electrodes 40 and/or therapeutic element 34 (for example, electrode) and be brought into contact with group
It knits.
Alternatively, may expand therapeutic element 34 may include at least one load bearing arm, which carries one or more
Therapeutic electrode (does not show that).
One or more mapping electrodes 40 can be used by navigation system 12, by equipment 16 control unit display and/
Or it is visualized in navigation system display.Further, each mapping electrodes 40 and therapeutic element 34 being connected to power supply can
To be conductive segment, with for specified tissue region convey electric signal, current or voltage and/or for measuring, recording, receive,
It receives, assess or otherwise using surrounding tissue or the one or more electrical properties or characteristic of other electrodes.It can be a large amount of
Different geometric configurations or the shape being controllably unfolded configure electrode, and electrode can be also quantitatively varied to adapt to
Specific application, targeted tissue structure or physiological characteristic.
Although not showing that, except monitoring, record or in other ways transmit Medical Devices 16 in measurement or condition or
Except ambient enviroment at 16 distal portions of Medical Devices, system 10 may include one or more sensors to monitor the system of spreading
Operating parameter, including in such as control unit 14 and/or Medical Devices 16 pressure, temperature, flow velocity, volume, power delivery,
Impedance etc..(multiple) sensor can be communicated with control unit 14 for starting during the operation of Medical Devices 16 or triggering
One or more alarms or treatment delivering modification.One or more valves, controller etc. can be communicated with (multiple) sensor to mention
Pass through the controlled distribution of inner cavity/fluid path or circulation of Medical Devices 16 for fluid.These valves, controller etc. can positions
In a part of Medical Devices 16 and/or in control unit 14.
Medical Devices 16 may include the handle 44 for being coupled to slender bodies portions of proximal 26.Handle 44 may include circuit, be used for
Mark and/or another component for controlling Medical Devices 16 or system.Additionally, handle 44 may also include connector, the company
Connecing device can match with control unit 14 to build between Medical Devices 16 and one or more part or parts of control unit 14
Vertical communication.Handle 44 may also include one or more actuatings or controlling feature, and one or more actuating or controlling feature allow
User controls from the proximal part of Medical Devices 16, deflection, turns to (steer) or manipulate the remote of Medical Devices 16 in other ways
End part.For example, handle 44 may include one or more components of such as lever or knob etc for manipulating Medical Devices
16 slender bodies 22 and/or additional component.
As used herein, term " control unit 14 " for simplicity may include be not Medical Devices 16 itself
A part, any system unit other than the component of navigation system 12 and imaging system 18, no matter the component whether object
Reason ground is located inside or outside control unit 14.Further, navigation system 12 can be the independence communicated with control unit 14
System may include in control unit 14 or being integrated in control unit 14, although navigation system 12 is illustrated as in Fig. 1
It is physically separated with control unit.Control unit 14 may include one or more components, the one kind used for delivery system or
Multiple kinds of energy form.For example, if system 10 be used to deliver cold therapy, control unit 14 can include: fluid supply 48,
Fluid coolant liquid, low-temperature refrigerant etc.；System is removed in discharge, is reused for recycling or discharging the fluid of consumption
Or disposition；And various controlling mechanisms.In addition to for fluid or coolant supply 48 discharge function is provided other than, control unit 14 may be used also
Handle 50, slender bodies 22 and/or Medical Devices 16 are delivered to including pump, valve, controller etc. to recycle and/or recycle
The fluid of fluid channel.Further, the vacuum pump in control unit 14 can be in one or more conduits in Medical Devices 16
Middle creation environment under low pressure is so that fluid is drawn into (multiple) conduit/inner cavity of slender bodies 22, simultaneously far from distal part 28
Towards the portions of proximal 26 of slender bodies 22.Additionally or alternatively, control unit 14 may include energy source 50, set as with medical treatment
The treatment or diagnosis mechanism that standby 16 (multiple) therapeutic element 34 communicates.As non-restrictive example, energy source 50, which can be, to be had
The radio-frequency signal generator of multiple output channels, wherein each channel is all coupled to single therapeutic electrode 34.Radio-frequency signal generator 50 can
To be operated with one or more operation modes.
Control unit 14 can further comprise one or more controllers comprising process circuit system, processor and/or
Software module 54, the process circuit system be configured for executing instruction or algorithm with provide to it is described herein and/
Or feature required by given medical procedure, sequence, calculating or program being automatically brought into operation and executing.In one embodiment, locate
Managing circuit system may include processor and memory.Memory can be with processor telecommunication and with instruction, and the instruction is in quilt
When processor executes, configures the processor and receive, handle or use in other ways the signal from equipment 16.Further,
Control unit 14 may include one or more user input equipments, controller and display 56, for collecting information to user
And transmit information to user.
System 10 can optionally include navigation system 12, the navigation system 12 can be suitble to control unit 14, set
Any commercially available navigation system being used together for 16 and any type program.As non-restrictive example, navigation system 12
Can include: multiple navigational electrodes 60, reference electrode (not shown) and processing unit 64, the processing unit are collected and are handled and come from
The signal of equipment mapping electrodes 40；And display 66, the display 66 show equipment 12 in patient's body and/or phase to user
For the position, recommended therapy region, tissue thickness etc. of target anatomic feature.Processing unit 64 may include processing circuit system
System, the process circuit system include memory and processor, and the memory is with the processor communication and with instruction, when the instruction
When being executed by the processor, configures the processor and execute calculating and determination discussed in this article.Additionally or alternatively, the information
It can be shown by the display 56 of control unit 14.Navigation system 12 may also include energy source (not shown), be used for multiple
Navigational electrodes 60 deliver energy.Alternatively, navigation system 12 can be communicated with control unit energy source 50.For example, processing unit 64
It can be configured, program or may be programmed and think Medical Devices mark solution for executing to calculate and make the determination discussed in greater detail below
It cuts open and learns feature and/or target position.Further, processing unit 64 can execute software and show software interface, and user can be with
It is interacted with the software interface to select, rotate or tag image, opened file folder, control navigation system 12 etc..As unrestricted
Touch screen, keyboard, mouse or other input equipments can be used to interact with software interface for example, user.
Navigational electrodes 60 (it is alternatively referred to as surface electrode) can be applied to the skin of patient 62, and can pass through patient Xiang Cheng
Tagmeme is set, current device location or target anatomic feature deliver the RF energy of rather low-frequency.Mapping electrodes in equipment 16
40 can respectively record voltage and impedance from the energy, and transmit data to processing unit 64, which then can be true
Mapping electrodes 40 (therefore also can determine equipment 16) are determined in position in patient body.It, can be in addition to the system based on impedance
Using other navigational electrodes, such as based on magnetic field, based on mixed impedance/magnetic field, based on ultrasound field and/or based on radiation
Navigation system and/or the following navigation system that may be developed.The calculating can be performed a plurality of times in processing unit 64 during process, frequency
Numerous update registration position and the content is shown to user, so that the user is able to real time inspection equipment relative to target anatomic
The position of feature.
System 10 can optionally include imaging system 18, which can be computed tomography (CT) system
System, magnetic resonance imaging (MRI) system or other systems for being suitable for creating the image of position in patient body.Imaging system 18 can be with
Navigation system 12 and/or control unit 14 communicate and digitally transmit image to it, to be further processed.Alternatively, by
The image that imaging system 18 records by user record and can be sent to navigation system 12 and/or control unit 14.
Referring now to Fig. 1 and Fig. 2, the distal part of example devices is described in more detail.As described above, equipment 16
It may include one or more therapeutic elements 34 and one or more mapping electrodes 40.In Fig. 1 and embodiment shown in Fig. 2,
At least part of distal part 28 can be used as therapeutic element 34, however, it is understood that mapping electrodes 40 can be optionally for energy
Amount transmitting.For example, distal part 28 can be thermally conductive and can be connected to energy source 50 and/or coolant source 48.Further,
Each electrode 40 may include thermocouple 68, for measuring and electrode 40 and/or the associated temperature of the tissue contacted with the electrode.
Each mapping electrodes 40 may include one or more conductive " trace " 70, be used as traditional electrode line (including heat
Galvanic couple line to).However, the trace can't be as traditional electrode line to the generation induration of slender bodies 22 or to cold therapy
Security risk (that is, the trace is not fed past expansion chamber) is presented in equipment.For sake of simplicity it is supposed that each electrode 40
All there is trace 70, no matter how many trace is contacted with each electrode.As shown in detail in figure 2, each mapping electrodes 40 can
With the remote communication of trace 70, and each trace 70 can from its associated electrode 40 to handle 44 on slender bodies 22 or
Internal stretch.The proximal end of each trace 70 can be communicated with handle 44 and/or control unit 14.Alternatively, each trace 70 is close
End can be communicated with scanning/Multiplexing module, which can transmit the signal for carrying out self-electrode 40 with high speed,
Whether or not using to the physics wired connection of control unit 14.
Further, each electrode 40 and trace 70 can be made of thermally conductive and/or conductive material, such as conductive nanometer
Particle.As non-restrictive example, conductive of material can be integrated into electrode 40 and 70 region of trace, be implanted slender bodies
In 22, integrates, and/or be deposited on slender bodies 22 with slender bodies 22.As non-restrictive example, nanoparticle can be applied to
The surface of slender bodies 22 or therapeutic element 34, or doping or be otherwise added to slender bodies 22 or therapeutic element 34 and (or set
Other standby any parts) material.Further, the region of conductive of material can have a flexible or compliance, the flexibility or
Compliance should be similar to or at least substantially identical as the flexibility of adjacent material or compliance, the flexibility of such as slender bodies 22 and comply with
Property.However, it should be understood that material can be located in the region for higher levels of thermal conductivity of it is expected to have part ownership than slender bodies 22 around.
In this case, the region of conductive of material may not be " electrode " with other systems component communication, and may only promote to set
Energy transmission between standby 16 and adjacent tissue.In this case, the region of conductive of material is referred to alternatively as therapeutic element；So
And for simplicity, the region of conductive of material is known as electrode 40. herein
In addition to keeping the flexibility of 16 distal part of equipment and the dissection for the tissue for being just studied and/or treating thus being avoided to become
Other than shape, the region of conductive of material also allows the single connection of device miniaturization, electrod-array to other systems component, and disappears
A possibility that except patient injury caused by the sharp or protruding edge as currently known electrode.
Conductive of material can be integrated into slender bodies 22 or be deposited on slender bodies 22, so that conductive of material
Region shows as typical strip electrode.However, the whole circumference that these electrodes 40 may and not enclose slender bodies 22 extends, phase
Instead, they may come from distal side by the interval at least with the interval between 40 both ends of an opening portion 72 or electrode
The trace 70 of electrode 40 is passed through.For example, equipment 16 may include distal tip electrode 40 '；For simplicity, other electrodes
40 can herein referred to as " band-like " electrode 40a ... 40n, wherein " n " represent it is any be greater than 1 number of electrodes, although each
There are at least one opening parts 72 for a electrode 40.Multiple electrodes 40 can be along the length of slender bodies 22 or apart from extension.Distal side
The trace 70 ' of point electrode 40 ' may pass through the opening portion 72a and farthest side band electrode 40a of farthest side band electrode 40a
All band electrode 40b ... 40n of nearside.The trace 70a of farthest side band electrode 40a may pass through next electrode 40b (its
Positioned at the nearside of farthest side band electrode 40a) opening portion 72b and band electrode 40b nearside all band electrodes
40c……40n.This can continue for " n " a electrode.Further, the nearest lateral electrode 40n of handle 44 can have opening portion
72n is greater than the opening portion 72a of farthest lateral electrode 40a, to allow the trace 70 of all electrodes 40 to extend there through.As a result,
Trace 70 can be in the square extension upwardly toward handle in distal side to nearside.
Electrode 40 can be partitioned into so that there are exist between first distance and 40 pairs of electrode between pairs of electrode 40
Second distance.As non-restrictive example, electrode 40b and 40c can be spaced apart first distance (about 2 millimeters), and electrode 40d and 40e
(or 40n, as shown in Figure 2) can also be spaced apart first distance (about 2 millimeters).However, first electrode pair (40b and 40c) and second
Electrode is to may be present second distance (about 5 millimeters) between (40d and 40e/40n).Farthest lateral electrode 40a and distal tip electrode
40 ' can be spaced apart third spacing (it is less than the first and second distances).
Alternatively, electrode 40 and trace 70 can have other configurations.As non-restrictive example, electrode 40 be can be linearly
(for example, as shown in Figure 3), snakelike (for example, as shown in Figure 4) or zone of dispersion (for example, as shown in Figure 5 and Figure 6).It replaces
Dai Di, trace 70 can be with the modes other than or the linear model shown in Fig. 2 different from linear model shown in Fig. 2 towards elongated
Body portions of proximal 26 extends.For example, trace 70 can in a spiral mode, fan pattern or with other any appropriate modes from elongated
Electrode 40 on body 22 proximally extends.Further, trace can be with scanning/Multiplexing module telecommunication, the scanning/Multiplexing module
Processing unit 64 then can will be transferred to flank speed by trace received signal, whether or not using physical wire line.
Implantation (or integrated) depth of 70 conductive of material of trace allows the continuous structure of distal part 28, for setting
Standby rigidity does not influence or only very little influences.For example, trace 70 can be located on the outer surface of slender bodies 22, mark in the position
Line is able to directly contact tissue or trace can be positioned at the lower face of slender bodies 22, and there is no straight for trace and tissue in the position
Contact (for example, being located in the wall of slender bodies 22).
As discussed above, electrode 40 and trace 70 can be by the conductive of material structures of such as metal nanoparticle etc
At.For example, the metal of such as platinum (Pt) and/or platinum-iridium (PtIr) etc may be used to form electrode 40, and thermocouple 68 can wrap
Include the intersection or platinum trace of golden (Au) trace and platinum trace and the intersection of palladium (Pd) trace.
Referring now to Figure 7, showing the embodiment for the Medical Devices being positioned in pericardial space.Show as unrestricted
Example, 16 distal part 28 of equipment can be inserted into pericardial space, such as by using entering under xiphoid-process.Distal part 28 can be from
First configuration of at least substantially linear is converted to the second expanded configuration.Here, distal part 28 can be therapeutic element 34
(for example, distal part 28 that coolant can cycle through neighbouring electrode 40) and there can be ring in expanded second configures
Shape configuration.
Ring-shaped therapeutic element 34 can be positioned in heart tissue, so that annular is completely (as shown in Figure 7) or at least partly
Surround destination organization 74.For example, the region of destination organization 74 can be the source and/or infarct zone of abnormal current.Mapping
Signal (such as electrogram, EGM) can be recorded from tissue by mapping electrodes 40, and the mapping signal can unit 64 processed
And/or control unit 14 informs whether the target tissue region is located in ring-shaped therapeutic element 34 for communicating to user.Once
Determine that therapeutic element 34 is located at desired locations, energy transmission can start.As non-restrictive example, control unit 14 can be by cooling
Agent cycles through slender bodies, and recycles in the distal part 28 for constituting therapeutic element 34.Additionally or alternatively, treatment member
Part 34 may include one or more therapeutic electrodes, and treatment energy can be delivered from the therapeutic electrode.Treatment energy delivering and/or cooling
Agent circulation can automatically or semi-automatically be initiated by control unit or manually be initiated by user.Subsequent electrode 40 can record monopole and/
Or the various combinations of bipolar impedance measurement, to carry out lesion assessment and/or assessment tissue amount of damage.It, can as non-restrictive example
Impedance measurement is recorded between electrode 40b and 40d, and impedance measurement can be recorded between 40a and 40c, or in electrode 40
Any one records impedance measurement between reference electrode 73.Enough damages are formed to be reduced by impedance and be indicated, the amount of reduction
Depending on frequency and electrode surface area (for example, the electrode that very small electrode can be bigger has higher impedance).
Referring now to Fig. 8 and Fig. 9, Medical Devices further embodiment is shown.As discussed above, equipment 16 can
Including inflatable element, which can optionally be used as therapeutic element 34.As non-restrictive example, system 10 and set
Standby 16 may be configured for cold therapy, and therapeutic element 34 can be inflatable balloon, and coolant can loop through this can
Inflating balloon.As shown in Figure 8 and Figure 9, may expand therapeutic element 34 may include one or more mapping electrodes 40, the mapping electrodes
Use conductive of material (such as metal nanoparticle) creation as discussed hereinabove.Conductive of material can be merged, be implanted into
Into therapeutic element, integrates and/or be deposited on therapeutic element with therapeutic element.
In the embodiment shown in fig. 8, therapeutic element 34 may include multiple dispersive electrodes 40, and each electrode 40 can wrap
Include trace 70.Alternatively, the region of conductive of material can not be communicated with the other component of equipment, and can only be used for enhancing thermally conductive
Property (such as compared with the thermal conductivity around inflatable therapeutic element 34), such as when equipment be used for such as cold therapy program when, should
Way can be useful.
In the embodiment shown in fig. 9, therapeutic element may include one or more elongated or at least substantially linear electrodes
40, each of the electrode includes trace 70.Alternatively, the region of conductive of material may not be with the other component of equipment
Communication, and can only be used for increased thermal conductivity (such as compared with inflatable 34 surrounding thermal conductivity of therapeutic element), above as closely
It is described.
Referring now to Figure 10, showing the embodiment for the Medical Devices being positioned in pericardial space.Show as unrestricted
Example, 16 distal part 28 of equipment can be inserted into pericardial space, such as by using entering under xiphoid-process.Distal part 28 can be from
The second configuration that the first configuration deflated is inflated as extension.
The therapeutic element 34 of extension can be positioned in heart tissue so that therapeutic element 34 completely (as shown in Figure 10) or
At least partly region of covering or contact target tissue 74.For example, the region of destination organization 74 can be abnormal current source and/
Or infarct zone.Mapping signal (such as electrogram, EGM) can be recorded from tissue by mapping electrodes 40, and the mapping
Signal can unit 64 processed and/or control unit 14 for communicating to user, inform whether the target tissue region is located at ring
In shape therapeutic element 34.Electrode 40 is not as it can be seen that because they are located between therapeutic element 34 and tissue in Figure 10.Once it is determined that
Therapeutic element 34 is located at desired locations, that is, starts energy transmission.As non-restrictive example, control unit 14 can allow coolant circulation
Flow through therapeutic element 34.Additionally or alternatively, therapeutic element 34 may include one or more therapeutic electrodes, and treatment energy can be by
Therapeutic electrode delivering.Treatment energy delivering and/or coolant circulation can by control unit or automatically or semi-automatically initiate or by
User manually initiates.Electrode 40 can record the various combinations of bipolar impedance measurement then to carry out lesion assessment.
Referring now to Figure 11 and 12, the embodiment of distal tip element is shown.Distal tip element 78 can be equipment
Component, the part of appliance are designed as by size and are configured for being attached in slender bodies distal part 28.For example, distal side is sharp
End element 78 may include first end 80 and second end 82, and the first end 80 may include barb bar 84, which can be inserted
Enter into the distal end of slender bodies 22.The second end 80 of distal tip element 78 can be circle or have other antisitic defect shapes.
The main body 86 of distal tip element 78 can be made of material identical with barb bar 84 or the barb bar 84 can be utilized than main body 86
The material of hardness higher (or flexible lower) is constituted.At least the material of main body 86 can be chosen so as to provide to main body 86 desired soft
Property, to allow it to meet irregular tissue surface.As non-restrictive example, main body 86 can be by nylon, polyurethane and/or poly- first
Radical siloxane (PDMS, also known as silicone resin) is constituted.
Distal tip element 78 can have one of conductive of material (metal nanoparticle such as discussed above)
Or multiple regions.The region of conductive of material can be used as mapping electrodes 40, but due to the thermal conductivity of its enhancing, these regions can also
It is used as navigational electrodes, impedance measurement electrode and/or therapeutic electrode.In the embodiment shown in fig. 10, electrode 40 has grid
Shape interval, wherein all electrodes are aligned each along the length of slender bodies 28 and surround the circumference of slender bodies 28.Shown in Figure 12
In additional embodiment, electrode has offset spacing.Although Figure 11 and Figure 12 show distal tip element 78 with multiple discrete circles
Shape electrode 40, it should be understood that the region of conductive of material can be any quantity, size or configuration, including but not limited to: straight
Linear, zigzag, snakelike, Curved etc..Optionally, the round second end 82 of distal tip element 78 may also comprise conductibility material
Material is to provide distal tip electrode to equipment.
It will be appreciated by those skilled in the art that the present embodiment is not limited to specifically illustrate above herein and describe interior
Hold.In addition, being referred to unless making with opposite above, it should be noted that all attached drawings are all not in proportion.In view of teaching above
Content, without departing substantially from following following claims range, numerous modifications and variations are possible.
Claims (14)
1. a kind of Medical Devices, the Medical Devices include:
Distal part, the distal part include: at least one therapeutic element, and the therapeutic element has the first flexibility；And
At least one mapping element, at least one described mapping element are the regions with the second Heat Conduction Material flexible, described second
It is flexible at least flexible essentially identical with described first.
2. Medical Devices as described in claim 1, which is characterized in that the Heat Conduction Material includes nanoparticle.
3. Medical Devices as claimed in claim 2, which is characterized in that the nanoparticle includes metal nanoparticle.
4. Medical Devices as claimed in claim 3, which is characterized in that the metal nanoparticle by platinum and platinum-iridium extremely
A kind of few composition.
5. Medical Devices as claimed in any one of claims 1-4, which is characterized in that the distal part is into one
Step includes at least one trace, and each of at least one described trace and at least one mapping element communicates, described
Each of at least one trace is made of Heat Conduction Material.
6. Medical Devices as claimed in claim 5, which is characterized in that each of at least one described trace has third
Flexibility, the third flexibility are at least flexible essentially identical with described first and second.
7. Medical Devices as claimed in claim 5, communicated with each of at least one mapping element described at least
One trace includes the first trace being made of the first metal and the second trace for being made of the second metal, and described first and second
Trace is thermocouple.
8. Medical Devices as claimed in claim 7, which is characterized in that first metal is one of gold and palladium, and described
Second metal is platinum.
9. Medical Devices as claimed in any one of claims 1-8 further comprise slender bodies, the distal portion
It is divided into the distal part of the slender bodies, at least one described mapping element is the Heat Conduction Material being integrated into the slender bodies
Region.
10. Medical Devices as claimed in claim 9, which is characterized in that the slender bodies has circumference, at least one described mark
Each of element is surveyed to extend around less than the whole of the circumference.
11. Medical Devices as claimed in any one of claims 1-10, which is characterized in that it is described at least one control
Treating element includes inflatable therapeutic element, at least one described mapping element is to be integrated into the inflatable therapeutic element
The region of Heat Conduction Material.
12. Medical Devices as claimed in claim 11, which is characterized in that the Heat Conduction Material includes metal nanoparticle.
13. Medical Devices as claimed in claim 11, which is characterized in that the distal part further comprises at least one mark
Line, each of at least one described trace and at least one described mapping element communicate, at least one described trace
Each is integrated into the inflatable element.
14. Medical Devices as claimed in claim 13, which is characterized in that each of at least one described trace is by thermally conductive
Material is constituted.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US15/418,264 US11369301B2 (en) | 2017-01-27 | 2017-01-27 | Highly flexible mapping and treatment device |
| US15/418,264 | 2017-01-27 | ||
| PCT/CA2018/050101 WO2018137044A1 (en) | 2017-01-27 | 2018-01-29 | Highly flexible mapping and treatment device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN110267591A true CN110267591A (en) | 2019-09-20 |
| CN110267591B CN110267591B (en) | 2022-08-12 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201880008667.2A Active CN110267591B (en) | 2017-01-27 | 2018-01-29 | High flexibility mapping and treatment device |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US11369301B2 (en) |
| EP (1) | EP3573526A4 (en) |
| CN (1) | CN110267591B (en) |
| WO (1) | WO2018137044A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| EP3788974A1 (en) * | 2019-09-05 | 2021-03-10 | Erbe Elektromedizin GmbH | Ablation probe |
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Also Published As
| Publication number | Publication date |
|---|---|
| CN110267591B (en) | 2022-08-12 |
| US20180214045A1 (en) | 2018-08-02 |
| WO2018137044A1 (en) | 2018-08-02 |
| EP3573526A4 (en) | 2020-10-21 |
| EP3573526A1 (en) | 2019-12-04 |
| US11369301B2 (en) | 2022-06-28 |
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